Training for Men Undergoing Androgen Deprivation Therapy.
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-80
SponsorThe Swedish School of Sport and Health Sciences
About this trial
The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy (ADT).
The main questions it aims to answer are:
* How feasible and safe is the new training concept? * How efficient is the training concept to counteract side effects caused by ADT?
Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects.
Participants in the intervention group will perform the new training concept twice weekly for 12 weeks. Participants in the control group will only receive usual care. All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
signed informed consent
histologically confirmed localised or locally advanced prostate cancer
planned radiotherapy in combination with ADT for at least six months (unfavorable intermediate risk and high-risk prostate cancer) with curative intent and with no known metastasis.
Disqualifiers
very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone
localized prostate cancer planned for radiotherapy without ADT
on-going or previously treated with ADT or other hormonal treatments
have any contraindications to physical testing/exercise as per the ACSM guidelines
Trial design
Design model
Parallel
Treatments tested in this trial
ADT-train
BehavioralA new training concept is tested on men with prostate cancer receiving androgen deprivation therapy
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ExerciseExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Aerobic fitness
VO2peak (ml/kg/min); incremental ramp test on a cycle ergometer
Time frame
Baseline and after 6 and 12 weeks2
Maximal leg strength
Isometric squat test (N) measured on force plates
Time frame
Baseline and after 6 and 12 weeksSecondary outcomes
1
Body fat
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Time frame
Baseline and after 6 and 12 weeks2
Lean body mass
Assessed by dual-energy x-ray absorptiometry (DEXA) (kg)
Time frame
Baseline and after 6 and 12 weeks3
Bone mineral density
Assessed by dual-energy x-ray absorptiometry (DEXA) (g/cm2)
Time frame
Baseline and after 6 and 12 weeks4
Quadriceps cross-sectional area
Assessed by ultrasound (mm)
Time frame
Baseline and after 6 and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Swedish School of Sport and Health Sciences
Lead sponsor
Norwegian School of Sport Sciences
Collaborator
Karolinska Institutet
Collaborator
Prostate Cancer Foundation
Collaborator
Sahlgrenska University Hospital
Collaborator
Source ClinicalTrials.gov